Extrait

Background and study aims There are over one billion Muslims in the world with the majority participating in Ramadan which is an integral part of Islamic identity. Muslims observing Ramadan are required to fast from sunrise to sunset during this holy month. During the summer season Ramadan can take place with the longest hours of daylight which has a greater impact and risk for people with diabetes who fast during this period. Although the Quran exempts “sick” people from the duty of fasting many Muslims with diabetes do not consider themselves to be sick and are keen to fast. The person with diabetes may not discuss fasting with their health care provider (HCP) if they are given generic advice not to fast due to diabetes. There is a lack of evidence available to help guide the management of people with diabetes who wish to observe Ramadan. One of the aims of this study is to determine the potential effects of fasting in people with diabetes on well-being and the management of this condition. Some known side-effects of fasting during Ramadan include low blood sugars (hypoglycaemia), high blood sugars (hyperglycaemia) and dehydration which may lead to hospitalisation. There have been significant advances in glucose lowering therapies in type 2 diabetes mellitus (T2DM) and their availability, thus offering a greater choice of therapies to people with diabetes with the potential for supporting safer fasting. Such therapies include the sodium-dependent glucose co-transporter-2 (SGLT2) inhibitors which increase glucose loss through the urine, resulting in lower blood glucose levels, improved diabetes control, weight loss and no hypoglycaemia risk. The present study will determine if the SGLT2 inhibitor Canagliflozin is effective in weight maintenance and improved diabetes control with less hypoglycaemic events compared with an established therapy (sulphonylureas, repaglinide or pioglitazone). Who can participate? Aged at least 25 and diagnosed with type 2 diabetes. Participants are also either treated with metformin alone (cohort 1) or metformin plus repaglinide, or a sulphonylurea or pioglitazone (cohort 2). What does the study involve? Participants are randomly allocated to one of four possible groups. Those in cohort 1 are treated with either Canagliflozin (Invokana™) or a second-line therapy (usually only given when the treatment of choice does not work) (repaglinide, or a sulphonylurea or pioglitazone). Those in cohort 2 either continue on their current treatment or switch to metformin and Canagliflozin (Invokana™). All participants are asked to visit the study centre at the start of the study (to be allocated to a group), 3-4 weeks post-Ramadan, 12 weeks post-Ramadan and, if they are enrolled >3months before Ramadan, participants also have an additional visit before Ramadan begins. All participants are assessed to see whether they have maintained a healthy weight and whether their diabetes is well controlled throughout the duration of the study. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? University Hospitals of Leicester NHS Trust and Queen Elizabeth Hospital Birmingham (UK) When is the study starting and how long is it expected to run for? August 2016 to September 2017 Who is funding the study? Janssen Pharmaceuticals Who is the main contact? Ms Natasha Wileman

Critère d'inclusion

• Specialty: Diabetes, Primary sub-specialty: Type 2; UKCRC code/ Disease: Metabolic and Endocrine/ Diabetes mellitus

Liens

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